Vigafyde

Pronunciation: VIG-uh-fide
Generic name: vigabatrin
Dosage form: oral solution
Drug class: Gamma-aminobutyric acid analogs

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 20, 2024.

What is Vigafyde?

Vigafyde (vigabatrin) is a ready-to-use oral solution that may be used to treat babies aged 1 month to 2 years of age with infantile spasms (IS) if the possible benefits of taking Vigafyde outweigh the potentially serious risk of permanent vision loss in the baby.

Vigafyde is an anticonvulsant that works in the treatment of infantile spasms by inhibiting the enzyme GABA transaminase, consequently increasing gamma-aminobutyric acid (GABA) levels in the brain which is thought to enhance seizure control by modulating neuronal excitability.

Vigafyde was FDA approved on June 17, 2024. Vigabatrin (the active ingredient) was first approved on August 21, 2009.

Vigafyde side effects

The most common side effects of Vigafyde reported in more than 5% of babies prescribed it include:

• sleepiness. Sleepy babies may have a harder time suckling and feeding or may be irritable
• ear infections
• swelling in the bronchial tubes (bronchitis)
• irritability.

Vigafyde causes decreases in liver enzymes (alanine transaminase [ALT] and aspartate transaminase [AST]  in up to 90% of patients) in up to 90% of patients. In some patients, these enzymes become undetectable. This may make detecting early liver damage difficult for your healthcare provider.

Vigafyde may increase the amount of amino acids in the urine, possibly leading to a false positive test for certain rare genetic metabolic diseases (such as alpha aminoadipic aciduria).

Serious side effects

Vigafyde can cause serious side effects and carries a black box warning for permanent vision loss. It can also cause changes in a brain scan (MRI).

Permanent vision loss

• Your baby is at risk for permanent vision loss with any amount of Vigafyde.
• Your baby’s risk of vision loss may be higher the dose of Vigafyde and the longer it is taken.

Vigafyde can damage the vision of anyone who takes it. Some people can have severe loss, particularly in their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, your baby may only be able to see things straight in front of them (sometimes called “tunnel vision”). Your baby may also have blurry vision. If this happens, it will not get better.

• Because of this risk, Vigafyde is used in babies 1 month to 2 years of age with infantile spasms only when you and your baby’s healthcare provider decide that the possible benefits are more important than the risks.
• Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe.
• Healthcare providers may not find vision loss in babies until it is severe. It is not possible for your baby’s healthcare provider to know when vision loss will happen. It could happen soon after starting Vigafyde or any time during treatment. It may even happen after treatment has stopped.
• It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting Vigafyde or within 4 weeks after starting it, and every 3 months after that until Vigafyde is stopped. Your baby should also have a vision test about 3 to 6 months after Vigafyde is stopped.
• Your baby may not be able to be tested. Your baby’s healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your baby’s healthcare provider may continue prescribing Vigafyde, but your baby’s healthcare provider will not be able to watch for any vision loss.

Tell your healthcare provider right away if you think that your baby is:

• not seeing as well as before taking Vigafyde
• acting differently than normal.

Even if your baby’s vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby’s vision before it is severe and permanent.

Because Vigafyde might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). It can only be prescribed to people who are enrolled in this program. As part of the Vigabatrin REMS, it is recommended that your baby’s healthcare provider test your baby’s vision from time to time (periodically) while your baby is being treated with

Vigafyde, and even after your baby stops treatment. Your baby’s healthcare provider will explain the details of the Vigabatrin REMS. For more information, go to www.vigabatrinREMS.com or call 1-866-244-8175.

Vigafyde may make certain types of seizures worse. You should tell your baby’s healthcare provider right away if your baby’s seizures get worse. Tell your baby’s healthcare provider if you see any changes in your baby’s behavior.

The following serious side effects have been reported in adults who take vigabatrin (the active ingredient in Vigafyde). It is not known if these side effects also happen in babies:

• low red blood cell counts (anemia)
• nerve problems. Symptoms of a nerve problem can include numbness and tingling in the toes or feet. It is not known if nerve problems will go away after treatment with Vigafyde is stopped.
• swelling
• suicidal thoughts and behavior.

Tell your healthcare provider if your baby has any side effect that bothers them or does not go away. These are not all the possible side effects of Vigafyde. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

vigabatrin

Warnings

Vigafyde may cause MRI changes in babies with infantile spasms. Brain pictures taken by MRI show changes in some babies after they are given Vigafyde. It is not known if these changes are harmful.

Do not suddenly stop giving your baby Vigafyde. This can cause serious problems. Stopping Vigafyde or any seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures. You should follow your baby’s healthcare provider’s instructions on how to stop taking Vigafyde.

Vigafyde may cause anemia (low red blood cell counts). Your healthcare provider will monitor your baby for this.

Vigafyde is not for use in children older than 2 years, adolescents, or adults.

What should I tell my baby’s healthcare provider before starting Vigafyde?

If you are a parent or caregiver whose baby has infantile spasms, before giving Vigafyde to your baby, tell your baby’s healthcare provider about all of your baby’s medical conditions, including if your baby has or ever had:

• an allergic reaction to Vigafyde or vigabatrin, such as hives, itching, or trouble breathing.
• any vision problems.
• any kidney problems.

How is Vigafyde administered?

Vigafyde comes as an oral solution. Give it exactly as your baby’s healthcare provider tells you to.

• Note that Vigafyde is more concentrated than other vigabatrin solutions prepared from powder. Vigabatrin contains vigabatrin at a dose of 100 mg/mL compared with other solutions that may only contain vigabatrin at 50 mg/mL.
• The volume of Vigafyde solution prescribed by your baby’s healthcare provider may be less than the volume prescribed for other vigabatrin solutions prepared from powder. Always double-check the volume (mL) that you are to give your baby when you get a new prescription filled.

You will receive Vigafyde for your baby from a specialty pharmacy.

• Vigafyde is usually given 2 times each day.
• Vigafyde can be given with or without food.

Vigafyde dosage

The dosage of Vigafyde depends on your baby’s weight and will change as your baby grows.

• Your healthcare provider will calculate this for you.
• The initial dosing is 50 mg/kg/day split into 2 doses (each dose is 25 mg/kg).
• Your baby’s healthcare provider may increase the dose if necessary.

Measure the dose for your baby exactly using the oral syringe provided by the pharmacy. Do not use a household teaspoon or tablespoon.

• Follow the detailed Instructions for use provided with the bottle.
• You can give Vigafyde to your baby at the same time as their meal.
• When measuring the dose, do not add water or other liquids to Vigafyde (do not dilute).

Do not use Vigafyde for a condition for which it was not prescribed. Do not give Vigafyde to others, even if they have the same symptoms. It may harm them.

If your baby is taking Vigafyde for infantile spasms and the seizures do not improve within 2 to 4 weeks, your baby’s healthcare provider will stop prescribing Vigafyde.

If Vigafyde improves your baby’s seizures, you and your baby’s healthcare provider should talk about whether the benefit of taking Vigafyde is more important than the risk of vision loss, and decide if your baby will continue to take it.

What happens if I miss a dose?

Before starting to give Vigafyde, talk to your baby’s healthcare provider about what you should do if you forget to give your baby a dose, or if your baby vomits, spits up, or only takes part of the dose.

What happens if I give my baby too much Vigafyde?

If you give your baby too much Vigafyde call your healthcare provider or seek emergency help right away. There is no specific antidote for a Vigafyde overdose. Standard measures to remove unabsorbed drugs should be used, including elimination by emesis or gastric lavage. Supportive measures should be employed, including monitoring of vital signs and observation of the clinical status of the patient.

What other drugs will affect Vigafyde?

Tell your baby’s healthcare provider about all your baby's medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Vigafyde and other medicines may affect each other causing side effects. Especially tell your healthcare provider if your baby takes:

• phenytoin, because Vigafyde can decrease phenytoin levels and a higher dosage of phenytoin may be needed
• clonazepam, because Vigafyde may increase plasma levels of clonazepam and increase the risk of side effects.

This is not a complete list of interactions. Talk to your healthcare provider or see the Vigafyde Package Insert for a full list.

Storage

Store unopened bottles at room temperature between 68°F to 77°F (20°C to 25°C). Once opened, store the bottle in a refrigerator or at room temperature between 36°F to 86°F (2°C to 30°C).

Throw away (discard) any opened bottle of Vigafyde 90 days after first opening, even if there is still medicine in the bottle.

Keep out of the reach of children.

Vigafyde ingredients

Active ingredient: vigabatrin.

Inactive ingredients: methylparaben, peppermint flavor, propylparaben, purified water, and sucralose.

The strength of the Vigafyde oral solution is 100 mg/mL.

Manufacturer

Pyros Pharmaceuticals, Inc.

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Further information

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